PERY GYN PACK- (1) DRAPE UTILITY WITH TAPE (1) DRAPE UNDERBUTIOCK WITH POUCH (1) TOWELS ABSORBENT 15" x 20" UF (2) LEGGINS W/7'' CUFF 30" X 42" (1 ) TABLE COVER REINFORCED 50" X 90" UF (1) DRAPE ABDOMINAL WITH TAPE UF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product code 900-1716, 53 lots: 109061244 109071562 109081820 109092024 109102291 109122762 110020332 110040902 110051214 110061438 110071671 110081969 110082177 110112616 110123093 111010064 111020274 111030598 111041097 111051278 111061509 111071907 111082062 111092362 111102697 111123377 112010084 112020402 112030640 112041197 112051869 112062445 112072783 112083403 112093912 112114382 112125030 113015433 113025947 113036671 113036754 113047005 113057396 113057862 113088757 113089198 113109747 131110329 131210758 140111169 140211650 140312082 140412456
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Customed, Inc
- Reason for Recall:
- Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
PERY GYN PACK- (1) DRAPE UTILITY WITH TAPE (1) DRAPE UNDERBUTIOCK WITH POUCH (1) TOWELS ABSORBENT 15" x 20" UF (2) LEGGINS W/7'' CUFF 30" X 42" (1 ) TABLE COVER REINFORCED 50" X 90" UF (1) DRAPE ABDOMINAL WITH TAPE UF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Product Codes/Lot Numbers:
Product code 900-1716, 53 lots: 109061244 109071562 109081820 109092024 109102291 109122762 110020332 110040902 110051214 110061438 110071671 110081969 110082177 110112616 110123093 111010064 111020274 111030598 111041097 111051278 111061509 111071907 111082062 111092362 111102697 111123377 112010084 112020402 112030640 112041197 112051869 112062445 112072783 112083403 112093912 112114382 112125030 113015433 113025947 113036671 113036754 113047005 113057396 113057862 113088757 113089198 113109747 131110329 131210758 140111169 140211650 140312082 140412456
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2406-2014
Related Recalls
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.